Jim Jeffords

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. JEFFORDS. Mr. President, with the medical device amendments of 1976, Congress intended that device classification and approval decisions be made based on the intended use of devices as described in labeling. In the 20th century, major strides in medical technology have revolutionized the practice of medicine. Thanks to achievements in such fields as fiber optics, imaging, biomaterials, electronics, and biotechnology, today's medical technology is faster, more efficient and more productive than ever. These achievements have provided benefits to individual patients and to society at large--benefits such as better health, more cost-effective medical treatments and the return of patients to productive lives more quickly. Today more than ever, medical technology is advancing at an astounding rate. Around the world, medical providers and device innovators are working together to bring better, more cost effective therapies to patients. That is what we are involved with here. So we want to keep in mind, and this is why we sometimes have an interesting dilemma, where you have something which the patients' groups are plotting and which the consumer groups sometimes take an opposite position on, based upon their fears that this process may lead to something getting on the market which might cause a problem and they do not have the confidence that is built into the oversight part. I urge people to understand, the devices we are talking about are important to health. If we delay, as has been the case here, delay after delay after delay, unnecessarily so, then those who need it, those who are trying to improve their health, are denied it because some are so concerned that the delays which are deemed, really, unnecessary, lead to people having devices denied them. Over the years, FDA has made premarket regulatory decisions based on uses for devices that are unrelated to the intended uses set forth in labeling. S. 830 includes two provisions that express the committee's specific intention to limit FDA's review of premarket submissions to the proposed labeling before the agency. Considerations like cost- effectiveness, relative effectiveness, or whether the product effects some improvement in a patient's quality of life, are irrelevant to a premarket review unless such claims are included in proposed labeling. Simply put, the FDA should not exceed its jurisdictional responsibilities by incorporating into the review process claims not before the agency for review consideration. For premarket notification submissions, the labeling proposed in the submission will be controlling of a device's intended use. If the intended use is the same or sufficiently similar to the intended use of a predicate device, then the device may be found to be substantially equivalent to the predicate. No considerations outside of the proposed labeling for the 510(k) device should bear on the question of whether or not the proposed labeling of the newer device is compatible with the labeling of the predicate device. For premarket approval applications, the determination of whether or not there is a reasonable assurance of device safety and effectiveness must be based on claims in proposed labeling if such labeling is neither false nor misleading. The FDA may fairly consider all facts which are pertinent to proposed labeling in PMA's in determining whether or not the labeling is false or misleading. Facts which are pertinent to proposed labeling are those which directly relate to claims in such labeling. For example, proposed labeling which states that a device is for use in treating atherosclerosis cannot be false or misleading because another device is more effective for that purpose. Nor can the proposed labeling be false or misleading because another device provides the same treatment benefits but is less expensive to purchase and operate. However, the failure to state a material fact about the device itself will make labeling in a pending PMA false or misleading. This provision, which has strong bipartisan support, provides a much needed element of due process to product reviews. We preserve all of FDA's enforcement authority and leave the agency wide discretion in making judgments about new products. What is at stake here? The ability of FDA to hold up a manufacturer's product on the basis of how a product might be used in the future--even if the company does not seek authority to market a product for those future uses. I think it will be helpful to delve a little deeper into the technical issues related to this amendment dealing with one part of section 404--it is worth a brief explanation of how FDA clears for marketing new products which are similar to older, legally marketed products, this is the 510(k) process. The agency considers whether the new product is substantially equivalent to the older one. In this process, FDA asks two questions. First, does the new product have the same intended use as the older product? Second, are there issues raised by technological differences in the new product compared to the older one? On the first question, FDA must not be allowed to second guess or impute new intended uses that the manufacturer does not claim-- essentially acting as judge and jury on that question. That is what our bill does. This is simply too subjective a question to allow FDA broad latitude. This bill would not allow that. If the product before FDA claims a legitimate intended use and the product can perform that intended use, this part of the test is met. But what if the new product has technological features not present in the older product which give rise to different safety and efficacy concerns? Under the bill, and it would certainly be my intent, FDA should and can demand data on those concerns or else not clear the product for marketing. That is what they do today, and that is what they would do under the bill. Further, if FDA determines that a manufacturer is promoting a product for a use that is not approved, all of its enforcement authority is available to correct that situation. Section 404 simply establishes a proper balance in the product review process and focuses FDA's authority on the more objective ground of technological considerations.

Mr. JEFFORDS. Mr. President, I now return to the Durbin amendment. Section 605, is also the subject of bipartisan agreement, with FDA's concurrence. By way of brief explanation, device tracking is intended to facilitate a product recall. Current law requires tracking for certain product types and also gives FDA discretion to require tracking for other products. It simply is not necessary for every device in the mandatory category to be subject to the tracking requirement. This provision allows FDA to affirmatively indicate which products in the mandatory category should be subject to tracking. FDA may use its discretion to add new products to the list of products which must be tracked or put a product back on the list for tracking if evidence indicates the need. This provision is needed because today, FDA will often indicate to a manufacturer that a product need not be tracked, even if it is in the mandatory category. While this many be good policy in the specific case, it puts both the FDA and the manufacturer in an undesirable legal situation. This provision allows FDA to exercise proper discretion and removes any potential cloud of legal liability which exists today. It is inconceivable that FDA would not require tracking in the tragic cases identified by the Senator. The provision in the bill is logical, safe, and necessary. Further, the GAO report cited by the Senator refers to areas of FDA control totally unrelated to device tracking and surveillance. Section 606: Postmarket Surveillance Some have asked why we have made the FDA's postmarket surveillance authority discretionary. I am pleased to address that question and I think my colleagues will understand the good reasons for doing so. First, let me clearly state the FDA is in full concurrence with the appropriateness of this policy. I should add that FDA has actually required relatively few products to conduct postmarket surveillance. It is important to differentiate between this authority and the medical device reporting [MDR] and user reporting programs which are unaffected by this provision. The Medical Device Reporter Program is the keystone to the postapproval system for identifying hazardous or defective medical devices on the market place. The MDR Program, coupled with FDA's authority to force product recalls and the device tracking provisions are a strong web of protection for the consumer. User reports, submitted to FDA and manufacturers by hospitals and physicians, are an additional layer of information on the status of medical devices in the healthcare system. Postmarket surveillance has a different purpose--to gather additional data to provide the extra assurance in the relatively rare situation where FDA has approved a product, yet still believes that the product should be subject to a limited period of postmarket evaluation. This is because for certain types of devices, problems may arise years after approval--problems which may not be detected in even the most elaborate clinical trial but could be dangerous to the individual, or even life threatening. It is instructive to consider the history of this authority. The Safe Medical Devices Act of 1990 included a provision requiring a manufacturer to conduct postmarket surveillance for any device first marketed after January 1, 1991, that is a permanent implant the failure of which may cause serious adverse health consequences or death, is intended for use in supporting or sustaining human life, or potentially presents a serious risk to human health. In other words, if you have something which can prevent death or serious injury, you certainly want to try it and use it, but you want to keep track of it to make sure if it proves to be the reverse in certain situations, that you at least know that and then can take appropriate action. In addition to this mandatory surveillance, FDA was authorized to require postmarket surveillance for any device when the agency determined that surveillance is necessary to protect the public health or to provide safety or effectiveness data. All manufacturers subject to mandatory postmarket surveillance were required to submit protocols for FDA approval within 30 days of first marketing the device. The FDA was required to determine the adequacy of the principal investigator and the protocol and to approve the protocol after review by an appropriately qualified advisory committee. In practice, the provision for mandatory surveillance, like the one for mandatory tracking, is so broadly worded that it is causing a good deal of uncertainty about those devices which are subject to this requirement. In some cases, companies and the FDA are technically exposed to unfair liability when the FDA does not require surveillance for products where it is, in fact, not necessary. We simply give FDA the discretion to require postmarket surveillance on any product it deems appropriate. This provision in no way suggests that FDA should cease to require surveillance for the types of devices it is currently covering under the existing authority. Indeed, we expect that FDA will by and large continue to require surveillance for most if not all of the products currently covered in the mandatory category. The committee and FDA believe this will be an appropriate way to bring clarity and efficiency to this important agency function. Indeed, FDA Director of Surveillance, Larry Kessler, recently said that he hoped Congress would join FDA in moving toward doing more discretionary and less required postmarket surveillance. They want to ensure that they can use their time as is most appropriate and most effective and efficient for their work, and not be required to do things which their judgment has found not necessary to take their time. So, for that reason I must oppose this, and as I pointed out, Senator Kennedy, as well as the FDA, would concur in opposition to this amendment. I think now I will take some of the time to go back and discuss the 404 situation here, why we are here. Senator Kennedy has taken extensive time last night and today. Certainly this is an important issue. It is an extremely important issue.

Mr. JEFFORDS. I am sorry to have to report, we have been trying in this last 45 minutes to see if we could move some amendments that everybody has agreed to and to show that we are really trying to bring this bill before this body and to make progress so we can decrease the amount of time that will be needed at the end as we move through the cloture process. Unfortunately, we have not been able to get that agreement. So such amendments as those of Senator Murray, Senator DeWine, and others, that would have been approved by unanimous consent by will have to wait for some future time in hopes that we can get agreement. I want to point out there are a large number of amendments pending on this bill, many of which are agreed to, others that probably will fall by the wayside, it should not be that difficult to finish work on this bill. However, if we continue to have this delay, without any cooperation to move the process forward, then it is going to foul up our very crowded calendar. That is unfortunate, as we all want to get the legislation done, get the conference reports on appropriations bills passed, and other pending legislation which is essential, so that we do not have to shut the Government down. If we fail to get the cooperation of the minority in even agreeing to things that everybody agrees to, it is unfortunate. Let me point out some of the Senators we would have helped today: Senator DeWine, for instance, and Senator Dodd; their amendments should have been agreed to. They have shown great leadership in advocating greater research into pediatric uses of new and existing drugs. Their amendment reflects Senator DeWine's successful effort to marry the mandated approach in the administration's regulations with the incentive-based approach underlying Senator DeWine and Senator Dodd's provision. Senator Murray has worked diligently to protect the health and safety of children. Her amendment, which everybody agrees should be approved, modifies the national uniformity provision clarifying that the exemption requirement is applicable to the health and safety of children. Other amendments by other Members that we could have adopted today will have to be done at some later time as long as the minority continues to block progress on the 152-page bill, of which 150 pages are agreed to. That does not make much sense. Why do we have this delay over a provision on which there is a disagreement, and general knowledge that the disagreement will have to be taken care of in the conference committee. The White House will insist that we come up with something different than is in the bill and the House has already taken a different position. Why should we delay the meeting of that conference committee? I urge the minority to let us vote--they are holding up an extremely important piece of legislation. The only advantage in doing this is to raise more public attention to one issue--that the minority is willing to tie up the Senate over one sentence in this bill in full knowledge that further work will be done on the issue in conference. So let's move this bill along, get it to conference. The House is moving expeditiously, so we can go to conference probably at the end of next week if we can get this bill done. I urge the minority to change the tactics of delaying any progress on this bill. I yield the floor.

Mr. JEFFORDS. I appreciate that clarification because this does get a little bit complicated as we move forward. This is an important issue. I think at this time I will just again restate that we believe that the bill as written adequately covers the problems of the conflict of interest situation. We commend the Senator from Illinois for really focusing attention on this and bringing it to our attention again so that all of my colleagues hopefully will understand that the bill--this is agreed to I believe also by Senator Kennedy--is effective in accomplishing the goals of the Senator from Illinois. So, again I commend him for what he has done. Madam President, I yield the remainder of my time.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, tomorrow morning the Senate will resume consideration of S. 830, the FDA reform bill. Under the previous order, Senator Kennedy will be recognized until 10:30 a.m. for debate only. As previously announced, there will be no rollcall votes on Friday. Following Senator Kennedy's remarks, Senator Durbin will be recognized to offer his two amendments. Those amendments are ordered to be set aside with the votes occurring on Tuesday, September 23, at 9:30 a.m. In addition, following the debate on Senator Durbin's amendments to the FDA reform, the Senate will proceed to a period of morning business. I thank all Senators for their attention.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I ask unanimous consent that Senator Stevens and Senator Byrd be added as conferees to H.R. 2378, the Treasury-Postal appropriations bill.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I ask unanimous consent that Senate proceed to the consideration of S. 1198, introduced earlier today by Senator Abraham.

Mr. JEFFORDS. Mr. President, I ask unanimous consent that the amendment be agreed to, the bill be considered read a third time and passed, as amended, the motion to reconsider be laid upon the table, and finally, any statements relating to the bill be placed at this point in the Record.

Mr. JEFFORDS. Mr. President, Senator Hatch has an amendment at the desk. I ask for its consideration.

Mr. JEFFORDS

Mr. JEFFORDS. For the information of all Senators, this cloture vote will occur immediately following the adoption of the committee substitute, which I hope will be by early afternoon on Tuesday, September 23.

Mr. JEFFORDS. Mr. President, I send a cloture motion to the desk on the FDA bill.

Mr. JEFFORDS. I ask unanimous consent the mandatory quorum under rule XXII be waived.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, as in executive session, I ask unanimous consent that the injunction of secrecy be removed from the following treaty transmitted to the Senate on September 18, 1997, by the President of the United States: Treaty with Australia on Mutual Assistance in Criminal Matters-- Treaty document No. 105-27. I further ask that the treaty be considered as having been read the first time; that it be referred with accompanying papers, to the Committee on Foreign Relations and ordered to be printed; and that the President's message be printed in the Record.

Mr. JEFFORDS

Mr. JEFFORDS. Therefore, I ask unanimous consent that, following the remarks of Senator Kennedy, as under the previous consent, the Senate stand in adjournment under the previous order.

Mr. JEFFORDS

Mr. JEFFORDS. I further ask consent that at 12 noon, the Senate proceed to a period of morning business with Senators being permitted to speak up to 5 minutes, with the following exceptions: Senator Coverdell or his designee, 90 minutes, from 12 noon until 1:30; Senator Daschle or his designee, 90 minutes from 1:30 until 3:00.

Mr. JEFFORDS. I also ask consent that at 10:30 a.m., Senator Durbin be recognized to debate his amendments under the previous order.

Mr. JEFFORDS. Mr. President, I ask unanimous consent that when the Senate completes its business today, it stand in adjournment until the hour of 9:30 a.m., on Friday, September 19. I further ask that on Friday, immediately following the prayer, the routine requests through the morning hour be granted and that the Senate immediately resume consideration of S. 830, the FDA reform bill, with Senator Kennedy being recognized until 10:30 a.m.

Mr. JEFFORDS

Mr. JEFFORDS. I move to lay that motion on the table. The motion to lay on the table was agreed to.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I ask unanimous consent that the Senate immediately proceed to executive session to consider the following nominations on the Executive Calendar, Calendar No. 253 and Calendar No. 254. I ask unanimous consent that the nominations be confirmed, the motion to reconsider be laid upon the table, any statements relating to the nominations appear at this point in the Record, the President be immediately notified of the Senate's action, and the Senate then return to legislative session.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, while we are waiting for a final draft of the amendment I intend to offer, I thought in the meantime I might just as well talk about it, and then we can take care of it when it is ready. Senator Torricelli and I had a very interesting time earlier this week in helping celebrate the aftermath of the reenactment of the Battle of Antietam which occurred this past weekend, which reenacted one of the most, if not the most, violent battles in the history of warfare in the Civil War. It was a remarkable experience, because not only were there thousands of people participating in the reenactment, but there also were over 100,000 people who watched the reenactment of that incredible battle which was, they say, the most bloody of the Civil War. It reminded me of this Nation, as we march on toward the end of this millennium, that we do have an obligation to make a commitment to ourselves in this interim before we go to the next millennium to ensure that we have learned the lessons of history, especially in this Nation, now the most proud and important and strongest Nation in the world, of how we formed and how we lived our lives up through the time it was created in respect to its modern form of people arriving from Europe and other places, and the struggles that we had which were not easy ones. We are still, in a sense, living some of the aftermath with respect to some of the biases and problems of discrimination in this Nation against those in the black community, who, as we all know, came over here as slaves, and then the great Civil War between the North and the South fought, to some extent, based upon the principles of the States rights, and yet also the very, very difficult question of abolishment of slavery in this country. I have had the opportunity over the course of time to study a great deal about that war, for Vermont was very dedicated and, in many ways, was the leader in the sense of commitment, for it was early on that Vermonters participated in a higher number per capita than any State in the North. In battle after battle, Vermonters were at the head of the troops. In fact, Lincoln at one time commented after reviewing the efforts of Vermonters, ``Just tell them to follow the Vermonters.'' When I was first in the Senate, our Vermont Legislature, in commemoration of the 100th year of the Battle of Cedar Creek--I guess it was a little longer than that, 120th, or something like that, because that was 1864, so I wasn't quite here yet, obviously. But anyway, they, in a sense, passed a resolution telling the Vermont delegation that they should go to the Battle of Cedar Creek and locate a monument which was erected there many, many years ago which commemorated the Vermonters. I will mention a little bit about that in a moment. We went there and had to locate it. It was at the back of a private house, and we found that it was all grown up and trees were winding in and out of the fencework around it. So we took immediate steps to get permission from the landowner and then transferred that information back to our legislature. But it brought to mind that before the memorabilia and memorials all disappeared, it would be important for us to try and see what we could do to retain them and make them available for future generations. So I introduced a bill to commemorate, in a sense, the battle in 1864 which led to the election of Lincoln, but also I became so entranced with Stonewall Jackson that I began to study the Stonewall Jackson campaign which occurred earlier in 1862 and recognized and realized from reading that it was the Jackson campaign in the Shenandoah Valley that led to a whole new concept of how to conduct war. In those battles, Stonewall Jackson took advantage of modern movement by the railroads. So he would appear in one place in Virginia, lodge a battle and then hop on a train and move to a totally different area, and in wonderment, he would appear miles and miles away and have another battle. So I came to the conclusion that it would make it very interesting if we could save those battlefields and to create a sort of historic trail with the Park Service so that people could, in a few days, start and follow the Stonewall Jackson campaign and move up through the Shenandoah Valley and then turn around and come back. That idea grew. Then attached to that at that time came the thought that we ought to take a look at conserving all battlefields that had a meaningful part of our history. Thus, the Battlefield Commission was created and the coin and all to try and fund it. That happened. Now we are coming, as I started to say, to the end of our century, the end of the millennium, and still much needs to be done to be able to make sure that the history and the battlefields which were the main battles of the Civil War are not lost for future generations. We have found that many of them are up for sale or the lands around them or critical pieces of land that were involved with those battlefields are up for sale. Thus, shortly we will be introducing an amendment to make sure that we do not lose the opportunity to provide the funding and the direction to the appropriate Federal officials to make sure that there are funds available to ensure that we can maintain the integrity of the main battlefields of the Civil War. I know my friend from New Jersey, who was with me as we thought about this and met with people this past week, joins me in this. I now yield the floor and allow him to participate in this discussion as we await the final draft.

Mr. JEFFORDS. Mr. President, I ask unanimous consent that reading of the amendment be dispensed with.

Mr. JEFFORDS. I move to lay that motion on the table. The motion to lay on the table was agreed to. Amendment No. 1217 (Purpose: Includes language limiting the expenditure of funds which may occur to fund the Forest Service's Juneau regional office)

Mr. JEFFORDS. Mr. President, I have an amendment at the desk.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I have enjoyed working with the Senator from Iowa. I think we have been together on every issue here over the course of the years. I have been with him, or just a little bit behind him, on all of these. I commend him for all the work he has done. We both know that without Bobby and Pat Morrissey, we would not have been as successful as we were.